Manufacturing certifications show that companies adhere to national and international standards. The NoCo Manufacturing Partnership offers basic information and links for additional information and certification details.
The International Standards Organization (www.Iso.org) began in 1946 when, after the Second World War, “delegates from 25 countries met at the Institute of Civil Engineers in London and decided to create a new international organization ‘to facilitate the international coordination and unification of industrial standards’” (www.ISO.org/iso/home/about.htm ). The organization now publishes 21,000 standards.
The purpose of the most common Quality Management System (QMS) standard, ISO 9001, is to allow an organization to demonstrate the ability to meet the requirements of its customers, plus applicable governmental requirements. It is based on seven “quality management principles” beginning with customer focus, and emphasizes an improvement cycle described as “Plan-Do-Check-Act.” Many in the supply chain consider a QMS certified to ISO 9001 as a basic requirement for approved suppliers.
Medical Device (ISO 13485)
Another common standard, ISO 13485, provides requirements for a QMS specific to the medical device industry, including design, production, installation and servicing. It contains many of the points required by the FDA as well, so it’s considered a ‘leg-up’ on FDA approvals.
Environmental Management (ISO 14001)
With concern for the health of the environment increasing, ISO 14001 was developed to provide guidelines for a “robust, credible and reliable EMS.” Few firms in Colorado have certified to this standard, leaving the market open to those firms who want to certify to this level. Manufacturers who choose to pursue this could increase their visibility and reputation through certification as a demonstration of how they manage their environmental footprint. The guidelines address more than simply reducing waste or recycling, many different areas are highlighted including water and power usage and pollutant reduction and control.
ASE AS9100: The Aerospace Standard
Under the umbrella of the Society of Automobile Engineers (founded in 1905 in New York City) aerospace engineers set industrial standards and guidance for design. The Aerospace Standard, AS9100, follows ISO 9001. The SAE webpage for AS9100d states “This standard includes ISO 9001:2015 quality management system requirements and specifies additional aviation, space, and defense industry requirements, definitions, and notes.”
Certification is available for this standard, just like ISO standards, though of course, the auditing requirements are more stringent. Certification to this standard allows a machine shop or manufacturing facility to enter the aerospace market, which can be lucrative. However, further down the supply chain, ISO 9001 certification is considered sufficient.
Should a manufacturer consider both ISO 9001 and AS9100 certifications? Generally, AS9100 should qualify a company for the commercial manufacturing supply chain, but customers have the last word.
Supply Chain Management
The American Production and Inventory Control Society, founded in 1957, offers certification to many different parts of the discipline broadly known as “supply chain management.” Far more than just a purchasing-department strategy to deal with vendors, end-to-end supply chain is a critical part of today’s complex manufacturing network. The website of the national organization, http://apics.org, lists multiple educational programs and certifications available.
A system of techniques and activities for manufacturing or service that focuses on eliminating waste can be called “lean.” The official Lean process focuses on seven areas: overproduction, waiting time in queue, transportation, non-value-adding processes, inventory, motion, and costs of quality including scrap. Lean emphasizes visual cues and workspace organization, among other tools, to achieve its goals. Lean is often combined with Six Sigma but can be emphasized in any QMS.
Simply put, Six Sigma is a method to reduce variation in processes, thus improving their capability of producing the desired results with less waste. It uses statistical and problem-solving tools, including the DMAIC approach and a supportive management environment, to achieve goals of 3.4 defects per million opportunities. First used in very large manufacturing environments, Six Sigma methods can be adapted to nearly any size organization. Individuals, not companies or processes, are certified, and various “belts” are involved, each at different levels.
More than 4,500 workers die on the job each year. Many more suffer injuries and are exposed to hazards contributing to disease and reduced lifespan. The Occupational Health and Safety Administration, www.osha.gov, is a Federal-level office governing workplace safety. Not limited to reducing slip-and-fall injuries, OSHA is concerned with issues such as hazardous substances and workplace violence, among others.
The often-feared OSHA audit (and fines) can be avoided, in most cases, by proper planning and vigilance. Free consultation is available from many sources, including through OSHA’s On-site Consultation Program.
Leadership in Energy and Environmental Design is a designation of the US Green Building Council (www.usgbc.org/about). This third-party certification for building design and construction emphasizes sustainability and resource-efficiency, which save money, water and energy. Now on version 4, LEED certification starts at the design level, all the way through construction and occupation. Four levels are available: Certified, Silver, Gold and Platinum. Existing buildings can also qualify, and whole neighborhoods can be certified. LEED and ISO 14001 go well together to design, control and reduce your company’s environmental impacts – contributing to your bottom line as well as the community.